Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioAlliance Pharma SA
ClinicalTrials.gov Identifier:
NCT00390780
First received: October 19, 2006
Last updated: September 5, 2013
Last verified: February 2013
Results First Received: September 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: miconazole Lauriad
Drug: Clotrimazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from 25 July 06 to 27 December 07 A total of 30 clinical sites (private practice and hospitals) in US, Canada and South Africa screened patients for this study, and 28 sites randomized patients

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no significant events or approaches following participant enrollment and prior to group assignment

Reporting Groups
  Description
Miconazole Lauriad Buccal Tablet Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole Troches Clotrimazole troches, 10 mg, 5 times per day, for 14 days

Participant Flow:   Overall Study
    Miconazole Lauriad Buccal Tablet     Clotrimazole Troches  
STARTED     291     287  
Treatment     290 [1]   287  
COMPLETED     268     260  
NOT COMPLETED     23     27  
Not completed                 10                 4  
Protocol Violation                 6                 4  
Lost to Follow-up                 3                 6  
Adverse Event                 2                 3  
Death                 1                 3  
Withdrawal by Subject                 1                 2  
Inclusion criteria not satisfied                 0                 2  
Lost to follow up and other reasons                 0                 1  
Investigator decision, SAE, other reason                 0                 1  
SAE, death                 0                 1  
[1] One patient randomized to miconazole lost study drug, never started treatment, and was discontinued.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Miconazole Lauriad Buccal Tablet Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Clotrimazole Troches Clotrimazole troches, 10 mg, 5 times per day for 14 days
Total Total of all reporting groups

Baseline Measures
    Miconazole Lauriad Buccal Tablet     Clotrimazole Troches     Total  
Number of Participants  
[units: participants]
  290     287     577  
Age  
[units: years]
Mean ( Full Range )
  37.5  
  ( 18 to 73 )  
  36.5  
  ( 18 to 72 )  
  37.0  
  ( 18 to 73 )  
Gender  
[units: participants]
     
Female     173     168     341  
Male     117     119     236  
Region of Enrollment  
[units: participants]
     
United States     67     62     129  
Canada     3     3     6  
South Africa     220     222     442  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale   [ Time Frame: 17 to 22 days ]

2.  Secondary:   Clinical Cure at Day 7 (Using Murray Scoring Scale)   [ Time Frame: 7 days ]

3.  Secondary:   Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)   [ Time Frame: 17 to 22 days ]

4.  Secondary:   Clinical Success at Day 7 (Using Murray Scoring Scale)   [ Time Frame: 7 days ]

5.  Secondary:   Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale   [ Time Frame: 17 to 22 days ]

6.  Secondary:   Mycological Cure at the Test of Cure Visit (Day 17-22)   [ Time Frame: 17 to 22 days ]

7.  Secondary:   Relapse at the Late Post-Therapy Visit (Day 35-38)   [ Time Frame: 35 to 38 days ]

8.  Secondary:   Oral Discomfort Using Visual Analog Scale (VAS)   [ Time Frame: 14 days ]

9.  Secondary:   General and Local Tolerability and Oral Discomfort   [ Time Frame: 14 days ]

10.  Secondary:   Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet   [ Time Frame: 14 days ]

11.  Secondary:   Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet   [ Time Frame: 7 days ]

12.  Secondary:   Susceptibility of Candida Species by Microdilution Test   [ Time Frame: Initiation of treatment to Day 17 to 22 ]

13.  Secondary:   Treatment Compliance   [ Time Frame: Initiation of treatment to Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr Pierre Attali
Organization: Bioalliance Pharma
phone: +33 (0)1 45 58 76 00
e-mail: pierre.attali@bioalliancepharma.com


No publications provided


Responsible Party: BioAlliance Pharma SA
ClinicalTrials.gov Identifier: NCT00390780     History of Changes
Other Study ID Numbers: BA/2004/01/04
Study First Received: October 19, 2006
Results First Received: September 7, 2012
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration